MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

Catalog Number 828806

Device Problem Complete Blockage (1094)

Patient Problem Failure of Implant (1924)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported an occluded shunt valve.A certas plus in-line valve was implanted in a patient via a ventricular peritoneal shunt secondary to a subarachnoid hemorrhage on an unknown date with an initial setting of 1.On an unknown date, the ventricles expanded and did not change when the pressure was changed.After pumping the shunt valve, the flow of cerebrospinal fluid could be confirmed temporarily, but it was immediately occluded.After confirming that the cerebrospinal fluid was not flowing, the patient was taken to the operating room on (b)(6) 2021 for a shunt valve revision.The patient recovered.

Event Description

N/a.

Manufacturer Narrative

The certas valve was returned for evaluation.Device history record (dhr): lot 5101882 showed 2 reports when released to stock on the 25th january 2021 the report issues had no link to this complaint.Failure analysis: the position of the cam when valve was received was at setting 1.The valve was visually inspected; the needle guard was raised and a cut/tear in the needle chamber was noted.The valve was hydrated.The valve was flushed and leaked from the cut/tear in the needle chamber, no occlusion noted at the ruby ball.The valve was leak tested and leaked from the cut/tear in the needle chamber.The catheters were irrigated, no occlusions noted.The valve was then pressure tested and the valve failed the test due to the cut/tear in the needle guard.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone housing base.The valve passed the test for programming, reflux and siphon guard.The root cause for the pressure issue noted during the investigation is due to the cut/tear in the needle chamber.The root cause for the cut/tear in the needle chamber is probably due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu, silicone housing has a low cut/tear resistance.The root cause for the problem reported by the customer could be due to the raised needle guard and the cut/tear in the silicone housing this is probably due to wrong handling as noted in the ifu: do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway, at the time of investigation no occlusion was noted.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11699351
• MDR Text Key: 247044215
• Report Number: 3013886523-2021-00175
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1